As is well known in the medical technology the surgical procedure for attaching a ventilating tube or grommet (sometimes referred to as a myringotomy tube or tympanotomy tube) into the tympanic membrane is by first making an incision into the membrane with a scalpel and next utilizing a releasing and holding tool or inserter to insert the implant into the incision in the tympanic membrane. Some ventilating tubes require suturing the grommet to the surrounding tissue in order to anchor the tube in place. In modern day technology the incision can be made by utilizing a laser or other cutting apparatus.
There are a number of ventilating tubes commercially available from, for example, Richards Medical Company in Memphis, Tenn. These ventilating tubes include, amongst others, the Shea Parasol, Shah LT, Shepard Grommet, Moretz-Type, and Rock Pediatric.
Listed are a number of patents that are exemplary of the types of ventilating tubes that are well known in the prior art. Amongst these include U.S. Pat. No. 4,094,303 granted to Johnston on Jun. 13, 1978 entitled "Tympanic Membrane Vent" which provides a grommet that is made from a hydrophobic porous material that allows the passage of air and also allows for tissue ingrowth.
U.S. Pat. No. 4,744,792 granted to Sander et al on May 17, 1988 entitled "Middle Ear Ventilating Tube" relates to a grommet type ventilation tube made from suggested biocompatible materials that resist extrusion while attempting to prevent clogging of the ventilation opening.
U.S. Pat. No. 4,695,275 granted to Bruce et al on Sep. 22, 1987 entitled "Middle Ear Ventilation Tube" is another ventilating tube that is made from a flexible material that is collapsible in order to facilitate the insertion of the tube in the slit or opening in the tympanic membrane.
U.S. Pat. No. 4,174,716 granted to Treace on Nov. 20, 1979 entitled "Myringotomy Tube" relates to a ventilating tube that is configured for the ease of insertion in the incision in the tympanic membrane.
U.S. Pat. No. 4,168,697 granted to Cantekin on Sep. 25, 1979 entitled "Middle Ear Ventilating Tube and Method" relates to another ventilating tube that includes a permeable membrane covering the outer end of the lumen formed in the grommet.
In each of the ventilating tubes disclosed in the above-noted references, the ventilating tube is inserted into a pre-cut incision. This procedure is complicated by the fact that the external auditory meatus is a circuitous and narrow passage, which is particularly so in enfants, that require a certain degree of skill to not only make the incision, but also insert the tube into the incision.
The present invention obviates the necessity of the pre-cut incision and simultaneously provides means for securing the ventilating tube to the tympanic membrane. Hence, in accordance with this invention the myringotomy tube simultaneously performs the functions of incising the tympanic membrane and insertion thereof. The cutting tang of the grommet is configured to impart a helical type path into the membrane to anchor the grommet to the membrane and hence, eliminate the necessity of suturing the grommet to the adjacent tissue.
In another embodiment of this invention, the inserter is disposable and is pre-assembled with the grommet which is releasably mounted on the distal end of the inserter so that the inserter/grommet assembly serves as the tool for incising and inserting the grommet in the tympanic membrane and the inserter after releasing the grommet is disposable. The invention contemplates the methods of construction and use of the combined inserter/grommet.